正交试验优选清湿外洗汤的煎煮工艺

A processes of decocting the Qingshi Waixi decoction by orthogonal test

目的:确立两煎常压煎药机所制清湿外洗汤的最佳煎煮工艺条件,为相似汤剂提供煎煮工艺标准。方法:以两煎常压煎药机所制清湿外洗汤中君药苦参的主要活性成分苦参碱的含量为考察指标,根据预设色谱条件-色谱柱:XTerra?Rp18(5μm,250mm×4.6mm),流动相:乙腈-乙二胺-水(45∶0.06∶55);流速:1.0ml/min;柱温:35℃;检测波长:220nm;进样量:10μl,采用四因素三水平正交设计表进行正交试验,对汤剂一煎时间、二煎时间、浸泡时间和煎煮加水量4个因素进行比较分析,通过直观分析和方差分析相结合,优选出最佳煎煮工艺条件,并对最佳煎煮工艺条件下制备的清湿外洗汤进行验证实验和微生物限度检查。结果:根据实验结果得出清湿外洗汤的最佳煎煮工艺条件为:第一次煎煮时间为30min,第二次煎煮时间为20min,浸泡时间为30min,煎煮加水量为1200ml。验证实验与正交试验结果一致,微生物限度检查符合《药典》标准。结论:按照优选最佳煎煮工艺条件制备清湿外洗汤效果良好,经验证,该煎煮工艺条件合理、稳定、可行,可用于制备清湿外洗汤,并可引申至相似汤剂的煎煮工艺。

Objective:To establish the optimal operation conditions of decocting the Qingshi Waixi decoction,to provide processstandard for similar decoction.Methods:The content of matrine in the Qingshi Waixi decoction as the inspection target,according to thepreset chromatographic conditions and orthogonal design table with4factor and3levels,4factor,including the first decocting time,thesecond decocting time,the immersion time,the volume of water were analyzed.Through the combination of visual analysis and varianceanalysis,the optimum conditions of the decoction were optimized,and the validation experiment and microbial limit test were carried out.Results:According to the experimental results,the optimal operation conditions of the Qingshi Waixi decoction were obtained;the firstdecocting time was30minutes;the second decocting time was20minutes,the immersion time was30minutes,and the volume of waterwas1200ml.The results of the verification experiment were consistent with the orthogonal test.Microbial limit test was accorded with thePharmacopoeia standard.Conclusion:The optimal operation conditions of decocting the Qingshi Waixi decoction show a good effect,andis reasonable,stable,feasible,and can be extended to similar decoction.